QLX — Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna Class II
FDA product code QLX covers "Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna", a Class II medical device regulated under 21 CFR 866.3183. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QLX
- Device Class
- Class II
- Regulation Number
- 866.3183
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant patients with active viral infection or at risk for developing viral infections. The test results are intended to be interpreted by qualified healthcare professionals in conjunction with other relevant clinical and laboratory findings.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243489 | abbott molecular | Alinity m EBV (09N43-095) | July 28, 2025 |
| K212778 | abbott molecular | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N | July 15, 2022 |
| K203220 | roche molecular systems | cobas BKV | January 29, 2021 |
| DEN200015 | roche molecular systems | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | July 30, 2020 |